REFERENCES
1. Gottschalk U. The renaissance of protein purification. BioPharm Int. 2007 Oct;Suppl:41–42.
2. Cheryl S. Meet the viruses. BioProcess Int. 2005 Nov; 3(Suppl 7):1–7.
3. International Conference on Harmonization. Q5A. Viral safety evaluation of biotechnology products derived from cell lines
of human or animal origin. Geneva, Switzerland; 1998.
4. European Commission (Enterprise Directorate General). EMEA Guideline on virus safety evaluation of biotechnological investigational
medicinal products. London: 2006 Jun 28.
5. Committee for Proprietary Medicinal Products (CPMP). Note for guidance on virus validation studies: the design, contribution
and interpretation of studies validating the inactivation and removal of viruses. CPMP/BWP/268/95;1996 Feb.
6. Anderson KP, Lie YS, Low MA, Williams SR, Fennie EH, Nguyen TP, Wurm FM. Presence and transcription of intracisternal
A-particle related sequences in CHO cells. J Virol. 1990;64:2021–2032.
7. Anderson KP, Low MA, Lie YS, Keller GA, Dinowitz M. Endogenous origin of defective retrovirus-like particles from a recombinant
Chinese hamster ovary cell line. Virol. 1991;181:305–311.
8. Dinowitz M, Lie YS, Low MA, Lazar R, Fautz C, Potts B, Sernatinger J, Anderson K. Recent studies on retrovirus-like particles
in Chinese hamster ovary cells. Dev Biol Stand. 1992;76:201–207.
9. Shi L, Chen Q, Norling LA, Lau AS, Krejci S, Xu Y. Real-time quantitative PCR as a method to evaluate xenotropic murine
leukemia virus removal during pharmaceutical protein purification. Biotechnol Bioeng. 2004;87(7):884–896.
10. CPMP. Note for guidance on quality of biotechnology products, viral safety evaluation of biotechnology products derived
from cell lines of human or animal origin. CPMP/ICH/295/95; London: 1997.
11. Walter JK, Nothelfer F, Werz W. Validation of viral safety for pharmaceutical proteins. In: Subramanian G, editors. Bioseparation
and bioprocessing, vol 1. Weinhemim, Germany; Wiley-VCH; 1998. p. 465–496.
12. Sofer G, Lister DC, Boose JA. Inactivation methods grouped by virus. Virus inactivation in the 1990s—and into the 21st
Century. BioPharm Int. 2003 Jun;Suppl:37–42.
13. Horowitz B, Lazo A, Grossberg H, Page G, Lippin A, Swan G. Virus inactivation by solvent/detergent treatment and the
manufacture of SD-plasma. Vox Sang. 1998;74 Suppl 1:203–206.
14. Charlebois TS, O'Connell BD, Adamson SR, Brink-Nilsson H, Jernberg M, Eriksson B, Kelley BD. Viral safety of B-domain
deleted recombinant factor VIII. Semin Hematol. 2001 Apr;38(2 Suppl 4):32–9.
15. Brorson K, Krejci S, Lee K, Hamilton E, Stein K, Xu Y. Bracketed generic inactivation of rodent retroviruses by low pH
treatment for monoclonal antibodies and recombinant proteins. Biotechnol Bioeng. 2003;82:321–329.
16. Zhou JX, Tressel T, Gottschalk U, Soalmo F, Pastor A, Dermawan S, et al. New Q membrane scale-down model for process-scale
antibody purification. J Chromatogr A. 2006;1134(1–2):66-73.
17. Zhou JX and Tressel T. Basic Concepts in Q membrane chromatography for large-scale antibody production. Biotechnol Prog.
2006;22(2):341–349.
18. Farshid M, Taffs RE, Scott D, Asher DM, Brorson K. The clearance of viruses and transmissible spongiform encephalopathy
agents from biologicals. Curr Opin Biotechnol. 2005;16:561–567.
19. Zhang R, Bouamama T, Tabur P, Zapata G, Gottschalk U, Mora J, Reif O. Viral clearance feasibility study with Sartobind
Q membrane adsorber for human antibody purification. IBC 3rd European Event BioProduction 2004, Antibody Production & Downstream
Processing; 2004 Oct 26–27; Munich.
20. Arunakumari Alahari, Wang JM, Ferreira G. Alternatives to protein A: Improved downstream process design for human monoclonal
antibody production. BioPharm Int. 2007 Feb Suppl;36–40.
21. Diehl T. Application of membrane chromatography in the purification of human monoclonal antibodies. Downstream Technology
Forum; King of Prussia, PA; 2006 Sept 28.
22. Schmidt S, Mora J, Dolan S, Kauling J. An integrated concept for robust and efficient virus clearance and contaminant
removal in biotech processes. BioProcess Int. 2005;3(8):26–31.
23. Brough H, Antoniou C, Carter J, Jakubik J, Xu Y, Lutz H: Performance of a novel Viresolve NFR virus filter. Biotechnol
Prog. 2002;18:782–795.
24. Tarrach K. Integrative Strategies for Viral Clearance. 4th Annual Biological Production Forum; 2005 Apr 7; Edinburgh.
25. Brorson K. CDER/FDA. Virus filter validation and performance. Recovery of Biological Products XII; 2006 Apr 2–7; Phoenix,
AZ.
26. Lamproye A. Viral clearance by nanofiltration, strategies for successful validation studies, 1st European Downstream
Forum. 2006 May 10; Göttingen, Germany.
27. Jones C, Denton A. Integration of large scale chromatography with nanofiltration for an ovine polyclonal product. 2nd
European Downstream Technology Forum. 2007 May 8; Göttingen, Germany.
28. Incardona NL, Tuech JK, Murti G. Irreversible binding of phage phi X174 to cell-bound lipopolysaccharide receptors and
release of virus-receptor complexes. Biochemistry. 1985;24:6439–6446.
29. Iwaya M, Eisenberg S, Bartok K, Denhardt DT. Mechanism of replication of single-stranded PhiX174 DNA. VII. Circularization
of the progeny viral strand. J Virol. 1973;12:808–818.
30. Willingmann P, Krishnaswamy S, McKenna R, Smith TJ, Olson NH, Rossmann MG, Stow PL, Incardona NL. Preliminary investigation
of the phage phi X174 crystal structure. J Mol Biol. 1990;212(2):345–50.
31. Tarrach K, Meyer A, Dathe JE, Sun Hanni. The effect of flux-decay on a 20 nm nanofilter for virus retention. BioPharm
Int. 2007 Apr;20(4):58–63.
32. Lute S, Balley M, Combs J, Sukumar M, Brorson K. Phage passage after extensive processing in small-virus-retentive filters.
Biotechnol Appl Biochem 2007 (In Press).
33. Wang J, Mauser A, Chao S-F, Remington K, Treckmann R, Kaiser K, Pifat D, Hotta J. Virus inactivation and protein recovery
in a novel ultraviolet-C reactor. Vox Sang. 2004 May;86(4):230-8.
34. Schmidt S, Kauling J. Process and laboratory scale UV Inactivation of viruses and bacteria using an innovative coiled-tube
reactor. Chem Eng Technol. 2007;30(7):945–950.
35. Tarrach K. Process economy of disposable chromatography in antibody manufacturing. development and production of antibodies,
vaccines, and gene vectors. WilBio's BioProcess Technology. Amsterdam: 2007 April 2–4.
36. Lim JAC, Sinclair A, Kim DS, Gottschalk U. Economic benefits of single use membrane chromatography in polishing, a cost
of goods model. BioProcess Int. 2007;5(2):60–64.
|